Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Granulated mesalamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767728

MPUC3004

Details and patient eligibility

About

The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

Full description

This is a Phase 3 study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared to placebo in subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g eMG (4 capsules total) or matching placebo capsules QD for 6 months.

The study consists of a screening phase (completed within 7 days prior to randomization), a treatment phase (6 months), and a follow-up visit (2 weeks after end-of-study [EOS] visit.) The treatment phase consists of 4 scheduled study visits: visit 1 (baseline/randomization (day 1), visit 2 (month 1), visit 3 (month 3), visit 4 (EOS (month 6).

Primary objective:

To compare the maintenance of remission from mild to moderate ulcerative colitis as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) of 1.5 g QD, as compared with placebo.

Secondary objective:

To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared to placebo in the maintenance of remission from mild to moderate UC.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month
• Greater than 18 years of age

Exclusion criteria

• Allergy/intolerance to aspirin, mesalamine, or other salicylates
• Prior bowel surgery other than appendectomy
• Pregnancy, at risk of pregnancy, or lactating
• HIV or hepatitis B or C

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Mesalamine pellets

Treatment:

Drug: Granulated mesalamine

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo